β-L-Thymidine/2′-deoxy-L-thymidine (telbivudine) is described in Coll Czech Chem Commun, Vol. 37, pp. 4072 (1972)/J Med Chem, 35, p. 4214ff (1992). Further, β-L-thymidine/2′-deoxy-L-thymidine's (telbivudine) use for the treatment of hepatitis B virus (HBV) is described in U.S. Pat. No. 6,395,716.
For administration to a pediatric population, a person with difficulties in swallowing or a renally impaired subject there is a need for an oral telbivudine solution.
An oral solution for aripiprazole is disclosed in Published US Patent Application No. 2002193438. However, these oral solutions are for the preparation of a sparingly soluble anti-schizophrenic compound and contain either lactic, acetic or tartic acid. Published International Application No. WO01/30318 provides an oral solution comprising galantamine in a non-buffered aqueous solution. However, an unbuffered aqueous solution would not guarantee that with time and storage conditions, the desired pH is maintained which would present a challenge for maintaining preservation of an oral solution. In addition, problems of bitterness of taste, stability of solution and microbial growth need to be overcome to prepare an oral telbivudine formulation. Disclosed herein is unexpected finding that specific preservative systems, aromatic types and concentrations, and solution pH can provide an oral telbivudine solution with pleasant taste, stability and retarded microbial growth.